The goal of GAP-Net is to build a global network of optimized clinical trial sites that are certified to meet industry-accepted quality and performance criteria. Sites selected to participate in GAP-Net have demonstrated abilities to increase participation in registries for clinical trials, accelerate enrollment from registries into current and future clinical trials, and establish high performance standards for participation in AD clinical trials in a manner consistent with GAP-Net metrics. GAP-Net sites will perform trials across all trial phases and all stages of Alzheimer’s disease. GAP-Net will also streamline administrative tasks such as budgeting, IRB clearance and contracting through the use of a common toolbox across sites. Through this work, GAP Net will reduce cycle time for clinical trials and increase trial standardization across a large network of sites.
The GAP-Net partners are top-performing, respected academic and private commercial institutions that share the goal of streamlining clinical research and drug development for Alzheimer’s disease. These sites are also committed to sharing information and fostering a collaborative environment across the network. To see a full list of our GAP-Net partners, please visit: memorystrings.org/research_network.
GAP Metrics and Goals
Each partner site focuses on achieving the goals for GAP-Net metrics. These goals are intended to drive improvement in both the timeline and the quality of clinical trials at the GAP-Net sites.
|Reduce the median time from sponsor protocol approval to 90% of Network Sites activated to enroll.||Reduce time for Network Sites by 33%|
|At the study level for Network Sites, increase the signal/noise ratio, as calculated by: [expected annual decline in cognition endpoint in placebo patients] / [standard deviation of decline observed in placebo patients in the study]||Increase study level S/N ratio by 10% at Network Sites, as measured by ADAS-cog**|
|Aligned Data Standards – Reduce the median time from Last Patient Visit to Data Lock “Ready” at Network Sites.||Reduce time for Network Sites by 33%|
|Data entered within 7 days of study visit; query responses logged within 7 days at Network Sites.||At 90% of Network Sites|
|Study participant non-safety related retention rate at Network Sites.||>90% retained per year**|
|Study enrollment performance expectations at each Network Site.||Network sites will perform 50% better than the benchmark.|
Please watch our GAP-Net site informative webinars here:
June 24, 2016
June 2016 GAP-Net Site Webinar
September 13, 2016
September 2016 GAP-Net Site Webinar